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FDA 510(k)

ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)

K-Number: K103643 · 2011-10-06

ApplicantAscot Technologies, Inc.
Decision Date2011-10-06
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) is the device name listed in this FDA 510(k) record. The listed applicant is Ascot Technologies, Inc.. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K103643. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)?

ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is Ascot Technologies, Inc.. The 510(k) number is K103643.

When did ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) receive FDA 510(k) clearance?

ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) received FDA 510(k) clearance on 2011-10-06, under 510(k) number K103643.

Who is the listed applicant for ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)?

The FDA 510(k) record lists Ascot Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)?

The FDA product code for ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) is DRG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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